Association Between a Mother's Exposure to "Strep Throat" and Her Baby's Developing Heart Disease

This study has been completed.

Sponsor:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT01603732

First Posted: May 23, 2012

Last Update Posted: April 4, 2017

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determine the history of maternal ß-hemolytic streptococcal exposure using a study questionnaire among HLHS mothers.

Determine "baseline" strep serologies and history of strep exposure among a cohort of asymptomatic pregnant women, identified at <18 weeks gestation and followed to term.

The overall purpose of this study is to evaluate the history of β-hemolytic streptococcal pharyngeal exposure, groups A, G and C ("strep throat") in pregnant women whose pregnancies have been complicated by the diagnosis of congenital heart disease. Our short-term goal is to identify a potential association of an antecedent maternal strep throat exposure in pregnancy to identify a subset of heart defects

To determine if co-infections play a role in congenital heart defects

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

Random Healthy Controls and Moms with fetal care/echos during pregnancy.

Criteria

Inclusion Criteria:

For Fetal pts:

HLHS or variant diagnosis

Other Congenital Heart Disease

Greater than or = 20wks gestation

For Healthy moms:

No diagnosis of Congenital Heart Disease

Greater than or = 20wks gestation

Exclusion Criteria:

For fetal pts & healthy controls:

Mom less than 18 years old

Twins or multiple gestations

Pregnancy affected by 2 or more congenital anomalies( in addition to heart defects)

Pregnancy affected by OB complications like pre-eclampsia

Known history of chromosomal anomaly or carrier status

Pregnancy result of fertility treatment including in vitro fertilization

Emotionally distress

Mom received blood transfusion or immunoglobin infusion within 6 months of the pregnancy.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603732

Locations

United States, Missouri

St Louis Childrens Hospital

St Louis, Missouri, United States, 63110

United States, Ohio

Cincinatti Children's Hospital Medical Center

Cincinatti, Ohio, United States, 45229

Sponsors and Collaborators

Washington University School of Medicine

National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Pirooz Eghtesady, MD,PhD

Washington University School of Medicine and St Louis Children's Hospital